With a phase 3 trial showing positive results, FDA approval could be coming in the next year
Results from a randomized controlled trial examining Cytisinicline were recently published in JAMA, showing that the drug led to superior smoking abstinence rates when compared to placebo and was well tolerated, with less than 10% of participants experiencing side effects. For context, some studies on varenicline have shown that 30% of people report nausea at the standard dose.
Dr. James Davis, MD, Associate Professor of Medicine and Medical Director for Duke Center for Smoking Cessation, offered some insight into this drug—how it works and potential implications for tobacco treatment in the US.
Cytisinicline is the trade name that has been given to cytisine, a plant alkaloid derived from the seeds of the Laburnum tree. Cytisine is currently used for smoking cessation under the name Tabex in Eastern Europe, but it has not been available in the US and is currently not FDA approved for smoking cessation.
How Cytisine Works
Cytisine is similar to varenicline but not as strong, explains Dr. Davis. Varenicline is currently the most effective medication available for smoking cessation. It blocks nicotinic receptors so that when a person on varenicline smokes a cigarette, nicotine from the cigarette cannot bind to nicotinic receptors in the brain. This makes smoking less rewarding or satisfying, which makes it is easier to quit. Unfortunately, varenicline has a high incidence of side effects, most commonly nausea and sleep problems—though some people also experience mood changes. Cytisinicline acts similarly to varenicline, blocking nicotinic receptors, but it does not bind to the receptors as tightly. This may explain why Cytisinicline appears to have a lower incidence of side effects.
Efficacy for E-Cigarette Cessation
Another recently published phase 2 trial showed that Cytisinicline was more effective than placebo for treatment of e-cigarette use, with participants 2.6 times more likely to quit with Cytisinicline. FDA approval of Cytisinicline for treatment of e-cigarette use will take a few years because phase 3 trials are still needed to demonstrate efficacy and safety in a larger population.
Dr. Davis says that if the FDA does eventually approve Cytisinicline for e-cigarette cessation, the impact would be huge, as there is currently no FDA-approved treatment for e-cigarette use. “This is something to look out for in the next 2 to 3 years.”
Implications for Tobacco Treatment in the US
Now that a phase 3 trial has shown the efficacy and safety of Cytisinicline for smoking cessation, the next likely step will be FDA approval for use as a smoking cessation agent in the US.
“It is likely that we may see a new smoking cessation medication available on the market in the next year or two – Cytisinicline – for use in patients smoking cigarettes,” says Dr. Davis. “Data suggests that it will be effective and well tolerated. Cytisinicline may provide a solution to the problem presented by varenicline: it is effective but has a high incidence of side effects.”
Side effects with varenicline cause patients to stop treatment or avoid using varenicline altogether. Cytisinicline could offer an alternative that is still effective for cessation with fewer side effects.
To learn more about the latest in tobacco dependence pharmacotherapy, don’t miss our upcoming half-day virtual CE training with Dr. James Davis: Tobacco Dependence Pharmacotherapy (8.0 CE hours) on December 5, 2023, from 12:00-5:00pm EST. Visit https://www.dukeunctts.com/shortcourses to learn more and register.
About the Author
Rachael Joyner, DNP, FNP-BC, APRN, is a family nurse practitioner with the Duke Smoking Cessation Program. She holds a National Certificate in Tobacco Treatment Practice and received her Doctorate in Nursing Practice from the University of Florida. She loves working collaboratively with patients to help them become tobacco free.